There seems to be an inordinate amount of attention on FISMA in the ongoing debate about how to establish a sufficient trust framework among public and private sector participants in health information exchange. Federal government security executives seem especially focused on the idea, still under development, that there needs to be a way to apply the security and privacy requirements government agencies are held to under FISMA to non-government entities when those non-government entities are part of an information exchange with the federal government. Leaving aside for the moment the suggestion that there may be a more suitable foundation (such as health information privacy regulations) on which to base security and privacy minimally acceptable requirements, there are at least three major problems with using FISMA as the basis of trust among information exchange participants.
The biggest issue is that while many of the security and privacy standards used and guidance followed by federal agencies under FISMA are common references, the provision of "adequate" security and privacy protections is entirely subjective, and as such differs from agency to agency. While all agencies use the security control framework contained in NIST Special Publication 800-53 to identify the sorts of measures they put in place, there are very few requirements about how these controls are actually implemented. Recent annual FISMA reports (including the most recently released report to Congress for fiscal year 2008) highlight the increase in the number and proportion of systems that receive authorization to operate based on formal certification and accreditation. The decision to accredit a system means that the accrediting authority (usually a senior security officer for the agency operating the system) agrees to accept the risk related to putting the system into production. Almost all federal agencies are self-accrediting, and each has its own risk tolerance in terms of what risks it finds acceptable and what it does not. Two agencies might not render the same accreditation decision on the same system implemented in their own environments, even using the same security controls. This lack of consistency regarding what is "secure" or "secure enough" presents an enormous barrier to agreeing on an appropriate minimum set of security provisions that could be used as the basis of trust among health information exchange participants, both within and outside the government.
Perhaps just as troubling, by focusing on FISMA requirements, the government is implicitly de-emphasizing the protection of privacy. To be sure, FISMA addresses privacy, most obviously in the requirement that all accredited systems be analyzed to identify the extent to which they store and make available personally identifiable information. These privacy impact assessments typically result in public notice being given detailing the data stored in and used by any system that handles personally identifiable information. But FISMA does not specify any actions for protecting privacy, nor does its accompanying NIST guidance include any controls to address privacy requirements stemming from the wide variety of legislation and regulatory guidance related to privacy.
It's not entirely clear what it would mean for a non-government organization to try to comply with FISMA requirements. As noted above, most federal agencies are self-accrediting, so presumably the determination of whether a non-government system is adequately secured against risk would rest with the organization itself. The basis for this determination (including the private-sector organization's risk tolerance) might be more or less robust than corresponding decisions made by federal agencies, so simply requiring non-government organization to follow a formal certification and accreditation process cannot establish a minimum security baseline any more than it does within the government. Few outside of government follow NIST 800-53, but many follow the similarly rigorous ISO/IEC 27000 security framework, so these organizations arguably would not need to adopt 800-53 if they already comply with an acceptable security management standard. (NIST has been working on an alignment matrix between 800-53 and ISO 27002, partly as a reflection of the similarity between the two standards and also in an effort to better harmonize public and private sector approaches.)
Even if some agreement can be reached wherein non-governmental entities agree to comply with FISMA security requirements, the law as enacted contains no civil or criminal penalties for failure to comply. Federal agencies judged to be doing a poor job with their information security programs receive poor grades on their annual FISMA report cards (fully half the reporting agencies received a grade of C or below for fiscal year 2007), but there is no correlation between budget allocations and good or bad grades, and no negative impact to poorly performing agencies other than bad publicity.
A better alternative (and one more consistent with master trust agreements like the NHIN Data Use and Reciprocal Sharing Agreement) would use privacy controls as a basis for establishing trust. One challenge in this regard is the number of different privacy regulations that come into play, making the HIPAA Privacy Rule alone (or other major privacy legislation) insufficient. Building a comprehensive set of privacy requirements and corresponding controls to be used as the foundation for trust in health information exchange is a topic we'll continue to address here.
11 hours ago